Central Virginia Firefighter's Association
P.O. Box 11854
Lynchburg Va, 24506-1854
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Alerts and Advisories from the USFA
Safety communication: HeartStart Automated External Defibrillators from Philips Healthcare may fail to deliver appropriate shock
The U.S. Food and Drug Administration issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare. Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.
NIOSH Respirators User Notice: Chemical Warfare Agent (CWA) Testing for NIOSH CBRN Respirator Approvals
The National Institute for Occupational Safety and Health (NIOSH) employs the Army Edgewood Chemical Biological Center's (ECBC) Test Laboratory to conduct the Chemical Warfare Agent (CWA) testing portion of Chemical, Biological, Radiological, and Nuclear (CBRN) testing. These services support the NIOSH respirator approvals providing CBRN protections. On November 18, 2013, ECBC notified NIOSH of errors with some of its test data. ECBC's internal assessment of these data indicates that concentrations of the CWAs used in testing were less than that required by NIOSH test procedures. Testing conducted during the period of July 2012 through October 2013 is affected. The majority of the affected testing was conducted in support of NFPA 1981, 2013 edition approvals in process. NIOSH evaluations for granting approval for CBRN protection require a broad range of testing in order to ensure protection at the levels indicated on the approval labels. The particular tests in question relate only to the ability of the respirator configurations to protect against CWAs. The affected respirator configurations will provide all of the non-CBRN protections for which the NIOSH approvals are issued. The non-CBRN protections are verified by NIOSH-conducted tests and evaluations. These NIOSH-conducted tests have not been compromised by the errors discovered in the CWA testing. However, the affected respirator configurations MUST NOT BE USED TO PROVIDE PROTECTION AGAINST CWA HAZARDS until retesting has verified that these protections are provided.
Nephron Pharmaceuticals Corporation Announces Voluntary Recall of Albuterol Sulfate Inhalation Solution, 0.083%
Nephron Pharmaceuticals Corporation (NPC) has initiated a voluntary recall, at the retail level, as a precautionary measure, due to results from internal monitoring processes. NPC is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. This voluntary recall will affect the following product: Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25). Ten (10) lots have been identified as impacted by this recall: A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.